9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University Hospital, Caen
- Enrollment
- 850
- Locations
- 32
- Primary Endpoint
- Thromboembolism occuring between day 7-35 ;
Study Overview
Brief Summary
The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 46 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First total knee joint replacement
- •Signed informed consent
- •Non-inclusion Criteria:
- •History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
- •Active cancer
- •Long-term anticoagulation
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Thromboembolism occuring between day 7-35 ;
Major bleeding occuring between day 7-35 ;
LMWH induced thrombopenia
All cause mortality
Secondary Outcomes
No secondary outcomes reported
